制药企业如何在已验证的清洁系统中引入新产品？

3.9 Introduction of New Productsto a Validated Cleaning System

将新产品引入到已验证的清洁系统

Whennew products or significantly different raw materials are introduced to theplant, a system must be in place to ensure that the cleaning process willremain effective.

当工厂引入新产品或明显不同的原料时，应有系统确保清洁程序仍然有效。

 

Generally,the cleaning effectiveness of the existing system for new products can betested by performing laboratory experiments using coupons of relevant materials(see Section 3.4 on Cleaning Development Laboratory Experiments). Theseexperiments can be designed to test both the effectiveness of the proposedcleaning regimen and the relative difficultyof cleaning the new soils compared to soils that have already been introducedto the plant. If the new soils are easier to clean than the most difficult soilalready being cleaned, introduction of the new material using existing cleaningprocedures can be made with confidence. If the material is more difficult toclean than each of the present soils, some modifications to the currentcleaning process may be required, and cleaning validation for the new productis an expectation. However, if the new soil is easier to clean, then based on arisk assessment, the number of confirmatory runs needed (if any) is determined.

通常，可进行相关材质试样试验测试现有清洁系统应用于新产品时的清洁效果（见3.4节实验室清洁工艺开发）。这些实验可以用来测试推荐的清洁方法的有效性，以及新污物和已有污物清洁的相对难度。如果新污物比原最难清洁污物更容易清洁，可采用现有清洁程序对新物质进行清洁。如果该物质比原来污物都更难清洗，则可能需要对现有清洁工艺进行调整，并对清洁工艺进行验证。如果新污物比原污物更容易清洁，可基于风险评估确定效果确认的次数（如果有）。